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Background End stage renal disease (ESRD) patients require a renal replacement therapy (RRT) to filter accumulated toxins and remove excess water, which are associated with impaired physical function. Hemodialysis (HD) removes middle-molecular weight (MMW) toxins less efficiently compared to hemodiafiltration (HDF); we hypothesized HDF may improve physical function. We detailed the design and methodology of the HDFIT protocol that is testing whether changing from HD to HDF effects physical activity levels and various outcomes. Methods HDFIT is a prospective, multi-center, unblinded, randomized control trial (RCT) investigating the impact of dialysis modality (HDF verses HD) on objectively measured physical activity levels, self-reported quality of life, and clinical/non-clinical outcomes. Clinically stable patients with HD vintage of 3 to 24 months without any severe limitation ambulation were recruited from sites throughout southern Brazil. Eligible patients were randomized in a 1:1 ratio to either: 1) be treated with high volume online HDF for 6 months, or 2) continue being treated with high-flux HD. This study includes run-in and randomization visits (baseline), 3- and 6-month study visits during the interventional period, and a 12-month observational follow up. The primary outcome is the difference in the change in steps per 24 h on dialysis days from baseline to the 6-month follow up in patients treated with HDF versus HD. Physical activity is being measured over one week at study visits with the ActiGraph (www.actigraphcorp.com). For assessment of peridialytic differences during the dialysis recovery period, we will analyze granular physical activity levels based on the initiation time of HD on dialysis days, or concurrent times on non-dialysis days and the long interdialytic day. Discussion In this manuscript, we provide detailed information about the HDFIT study design and methodology. This trial will provide novel insights into peridialytic profiles of physical activity and various self-reported, clinical and laboratory outcomes in ESRD patients treated by high volume online HDF versus high-flux HD. Ultimately, this investigation will elucidate whether HDF is associated with patients having better vitality and quality of life, and less negative outcomes as compared to HD. Trial registration Registered on ClinicalTrials.gov on 20 April 2016 (NCT02787161). Electronic supplementary material The online version of this article (10.1186/s12882-019-1247-8) contains supplementary material, which is available to authorized users.

Submitted by Vitor Silverio Rodrigues (vitorsrodrigues@reitoria.unesp.br) on 2014-05-27T11:25:30Z No. of bitstreams: 0Bitstream added on 2014-05-27T14:31:08Z : No. of bitstreams: 1 2-s2.0-79952197520.pdf: 336059 bytes, checksum: 6887bfb6c66c449f86ed80f9d7459718 (MD5) Made available in DSpace on 2014-05-27T11:25:30Z (GMT). No. of bitstreams: 0 Previous issue date: 2011-03-05 Background: Blood pressure (BP) within pre-hypertensive levels confers higher cardiovascular risk and is an intermediate stage for full hypertension, which develops in an annual rate of 7 out of 100 individuals with 40 to 50 years of age. Non-drug interventions to prevent hypertension have had low effectiveness. In individuals with previous cardiovascular disease or diabetes, the use of BP-lowering agents reduces the incidence of major cardiovascular events. In the absence of higher baseline risk, the use of BP agents reduces the incidence of hypertension. The PREVER-prevention trial aims to investigate the efficacy, safety and feasibility of a population-based intervention to prevent the incidence of hypertension and the development of target-organ damage.Methods: This is a randomized, double-blind, placebo-controlled clinical trial, with participants aged 30 to 70 years, with pre-hypertension. The trial arms will be chlorthalidone 12.5 mg plus amiloride 2.5 mg or identical placebo. The primary outcomes will be the incidence of hypertension, adverse events and development or worsening of microalbuminuria and of left ventricular hypertrophy in the EKG. The secondary outcomes will be fatal or non-fatal cardiovascular events: myocardial infarction, stroke, heart failure, evidence of new sub-clinical atherosclerosis, and sudden death. The study will last 18 months. The sample size was calculated on the basis of an incidence of hypertension of 14% in the control group, a size effect of 40%, power of 85% and P alpha of 5%, resulting in 625 participants per group. The project was approved by the Ethics committee of each participating institution.Discussion: The early use of blood pressure-lowering drugs, particularly diuretics, which act on the main mechanism of blood pressure rising with age, may prevent cardiovascular events and the incidence of hypertension in individuals with hypertension. If this intervention shows to be effective and safe in a population-based perspective, it could be the basis for an innovative public health program to prevent hypertension in Brazil.Trial Registration: Clinical Trials NCT00970931. © 2011 Fuchs et al; licensee BioMed Central Ltd. Hospital de Clínicas de Porto Alegre Universidade Federal do Rio Grande do Sul, Porto Alegre Hospital Universitário Antônio Pedro Universidade Federal Fluminense, Niterói Hospital São Lucas Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre Hospital das Clinicas Universidade de São Paulo, São Paulo Instituto do Coração Universidade de São Paulo, São Paulo Faculdade de Medicina de Ribeirão Preto Universidade de São Paulo, Ribeirão Preto Faculdade de Medicina São José do Rio Preto, São José do Rio Preto Faculdade de Ciências Médicas Universidade de Campinas, Campinas Faculdade de Ciências Farmacêuticas Universidade de São Paulo, Ribeirão Preto Faculdade de Medicina de Botucatu Universidade Estadual de São Paulo, Botucatu Universidade do Estado do Rio de Janeiro, Rio de Janeiro Hospital das Clínicas Universidade Federal de Minas Gerais, Belo Horizonte Hospital das Clínicas de Goiânia Universidade Federal de Goiás, Goiânia Anis Rassi Hospital, Goiânia Hospital Universitário Júlio Muller Universidade Federal de Mato Grosso, Cuiabá Faculdade de Medicina Universidade de Ciências da Saúde Alagoas, Maceió Faculdade de Medicina Universidade Federal de Pernambuco, Recife Instituto de Medicina Integral Prof Fernando Figueira, Recife Hospital Universitário Oswaldo Cruz/PROCAPE Universidade de Pernambuco, Recife Hospital Universitário Valter Cantídio Universidade Federal do Ceará, Fortaleza Hospital Universitário Universidade Federal Maranhão, São Luiz Instituto de Cardiologia Fundação Universitária de Cardiologia, Porto Alegre Faculdade de Medicina Universidade Federal de Pelotas, Pelotas Hospital do Coração, São Paulo Faculdade de Medicina de Botucatu Universidade Estadual de São Paulo, Botucatu